About this trial
This prospective observational study aims to determine whether specific parameters measured by transcranial Doppler ultrasound (TCD) can predict clinical outcomes in patients with acute ischemic stroke (AIS). The primary objective is to evaluate the association between middle cerebral artery (MCA) flow velocities and short-term neurological improvement. Secondary outcomes include the presence of collateral flow and flow patterns in relation to functional recovery measured by NIHSS and modified Rankin Scale (mRS) scores.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Clinical diagnosis of acute ischemic stroke
Onset of symptoms ≤ 24 hours before admission
Underwent or will undergo transcranial Doppler ultrasound within 24 hours of symptom onset
Disqualifiers
Evidence of intracerebral hemorrhage on imaging
Inadequate temporal acoustic window for transcranial Doppler
Intubated or hemodynamically unstable prior to Doppler evaluation
Known diagnosis of neurodegenerative disease significantly affecting baseline neurological function (e.g., advanced dementia, Parkinson's disease)
Trial design
Single group
Treatments tested in this trial
Transcranial Doppler Ultrasound
Diagnostic testA non-invasive bedside diagnostic procedure used to measure cerebral blood flow velocities and pulsatility index in intracranial arteries, primarily the middle cerebral artery (MCA). The test is performed within the first 24 hours of symptom onset using standard ultrasound equipment with a 2-MHz probe. The data collected is used solely for prognostic evaluation and does not influence treatment decisions.
Treatment groups
Trial outcomes
Primary outcomes
Change in NIHSS score from baseline to 72 hours
Neurological status will be assessed using the National Institutes of Health Stroke Scale (NIHSS) at baseline (upon admission) and again at 72 hours. The primary objective is to evaluate the correlation between initial transcranial Doppler (TCD) measurements-specifically, mean flow velocity and pulsatility index in the middle cerebral artery-and the degree of clinical improvement or deterioration, as reflected by changes in NIHSS score. A greater reduction in NIHSS score indicates better neurological recovery. The NIH Stroke Scale (NIHSS) is a standardized, 15-item clinical assessment tool used to evaluate the severity of neurologic deficits in patients with acute stroke. The total NIHSS score ranges from 0 to 42, where: 0 = no stroke symptoms Higher scores indicate greater stroke severity and worse neurological outcomes The scale includes assessments of level of consciousness, gaze, visual fields, motor strength, limb ataxia, sensory function, language, and neglect.
Secondary outcomes
Presence of collateral circulation associated with ≥ 4-point NIHSS improvement
Collateral circulation will be assessed using transcranial Doppler ultrasound within 24 hours of symptom onset. Collaterals will be defined as the presence of cross-flow or increased velocity in the anterior or posterior communicating arteries. Clinical improvement is defined as a reduction of ≥4 points on the NIHSS score from baseline to day 7. The association between collateral flow and neurological improvement will be analyzed. The NIH Stroke Scale (NIHSS) is a standardized, 15-item clinical assessment tool used to evaluate the severity of neurologic deficits in patients with acute stroke. The total NIHSS score ranges from 0 to 42, where: 0 = no stroke symptoms Higher scores indicate greater stroke severity and worse neurological outcomes The scale includes assessments of level of consciousness, gaze, visual fields, motor strength, limb ataxia, sensory function, language, and neglect.
Functional status at discharge (modified Rankin Scale)
The patient's functional outcome will be assessed at discharge using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death). The distribution of mRS scores will be analyzed in relation to transcranial Doppler findings, including mean flow velocity, pulsatility index, and flow pattern, to determine their prognostic significance.
Locations
Sponsors and contacts
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Jose Ivan Rodriguez de Molina Serrano
Lead sponsor
Clinica Mexico
Sponsor institution
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